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Monday, January 23, 2017

Image-Guided Cryoablation for the Treatment of Phantom Limb Pain in Amputees: A Pilot Study

Phantom limb pain (PLP) affects up to 50-80% of patients with limb loss amputations. This condition is defined by unpleasant, often painful, sensations that are perceived to originate from the amputated limb. Prologo et al present the results of a single-arm pilot study with 21 patients investigating the efficacy of percutaneous cryoneurolysis for treatment of PLP refractory to conventional treatments. The study patients underwent a two-step protocol consisting of initial computed tomography-guided perineural injection with 0.25% bupivacaine and betamethasone. If initial injection improved PLP symptoms, the patients underwent cryoneurolysis at a later date. Study endpoints included changes in pain intensity and functional impairment as measured by a visual analog scale and the Roland Morris Disability Questionnaire, respectively. At 7-days post-cryoablation, pain intensity scores decreased by 0.8 (5.4 versus 6.2) and functional impairment decreased by 1.9 (9.4 versus 11.3) compared to baseline; however, these changes were not statistically significant. At 45-days post-cryoablation, pain intensity scores decreased by 3.9 (2.3 versus 6.2) and functional impairment decreased by 8.0 (3.3 versus 11.3) compared to baseline, and these changes were statistically significant (p<0.0001). There were no statistically significant differences in pain intensity and functional impairment scores between the 45-day post-procedure visit and long-term follow-up visits (194 days +/- 99 days). Four patients volunteered to undergo repeat cryoablation and demonstrated consistent response to the second treatment with respect to both functional impairment and pain intensity score improvement. There was 100% technical success in the study with no reported adverse events related to treatment or participation in the study. Six patients (29%) required additional nonsteroidal anti-inflammatory drugs during the initial days following cryoneurolysis due to procedure related pain.

Commentary

This pilot study by Prologo et al provides preliminary data demonstrating safety and efficacy of cryoneurolysis for reducing refractory phantom limb pain. At 45-days post-treatment, patients demonstrated significant decreases in both pain intensity and functional impairment. The study had 100% technical success and no reported adverse events related to treatment or inclusion in the study. Interestingly, pain in the residual limb was a significant covariate for both baseline pain intensity and response to cryotherapy. Patients with residual limb pain had lower baseline pain and less overall change in pain intensity compared to patients without residual limb pain. This study was limited as a pilot study without a control arm or randomization. In addition, the authors did not collect or evaluate medication logs to determine how treatment affected use of pain control medication. The reported exploratory data; however, supports the design of a larger, parallel-arm randomized controlled trial in the future with more comprehensive outcome measurements. Overall, percutaneous cryoneurolysis has the potential be a safe and effective treatment option for refractory PLP.